JP2022500113A - Folded Porous Internal Growth Features for Medical Implants - Google Patents

Abstract

The present disclosure provides a bent porous metal scaffold that can be used as a bone internal growth feature of a medical implant.

Description

[Related application]
This application claims the priority of US Provisional Application No. 62/727219 entitled "Folded Porous Ingrowth Features for Medical Implants" filed September 5, 2018, which is incorporated herein by reference in its entirety. ..

Existing specific medical implant features cannot grow bone over the entire feature of the implant, as the feature conventionally comprises a solid substrate coated with a porous substrate. Such a solid substrate cannot grow bone over the entire feature. Also, such solid substrates make it difficult or impossible to modify features with standard orthopedic saw blades.

Accordingly, the present application discloses compositions and methods that provide implantable medical devices with features that provide better internal bone growth and more regional modification properties.

The present disclosure relates to rigid, complex, three-dimensionally shaped medical implants that can be fixed to bone. As disclosed herein, a bent porous metal scaffold allows internal bone growth throughout the scaffold. The devices and methods of the present disclosure bring the rough surface of a bent porous scaffold into contact with bone. In addition, the scaffold can be cut with a standard orthopedic saw blade, and the modification to the desired shape can be easily completed.

Therefore, in the first aspect, the present disclosure has continuous porosity, a rough surface and a smooth surface, one or more portions of the rough surface are present on the exposed surface of the device, and one or more portions of the smooth surface. Bent metal with one or more porous metal scaffolds that are bent so that they are in contact with each other and are not exposed to the surface of the device and one or more other parts of the smooth surface are exposed to the surface of the device. Provided is a porous bone internal growth device. One or more parts of the smooth surface exposed on the surface of the device may be configured to be attached to a medical implant. The one or more bent metal porous scaffolds can be one or more sheets having a thickness of approximately 0.5 mm before bending. One or more porous metal scaffolds have a continuous porosity between about 175 μm and about 300 μm, an average porosity between about 50% and about 69%, and a diameter in the range of about 400 μm to about 700 μm, respectively. It may have multiple pores. Two or more of one or more porous metal scaffolds can be attached to each other. Folded metal porous bone internal growth devices include one or more biological materials such as stem cells, bone marrow concentrates, platelet-rich plasma (PRP), transplanted tissue pieces, microscopic bone, combinations thereof. Etc. can be coated. One or more porous metal scaffolds may include continuous pore metal sheet scaffolds. The rough surface of one or more porous metal scaffolds may have multiple material bumps. The multiple material ridges that form the rough surface of the device can be harder than the cortical bone. The plurality of material ridges forming the rough surface of the device may have edges defining one or more bends forming a curved perimeter. Multiple material ridges forming the rough surface of the device may have edges that define a linear angle. The plurality of material bumps forming the rough surface of the device can have a thickness in the range of approximately 100 μm to approximately 1000 μm.

In a second aspect, the disclosure provides a medical device comprising a medical implant and a bent porous metal scaffold bone internal growth device attached to the medical implant. The bent porous metal scaffold bone internal growth device can be coated with one or more biomaterials.

In a third aspect, the present disclosure provides a method of manufacturing a bent metal porous bone internal growth device. In this method, one or more porous metal scaffolds or one or more scaffold layers having a rough surface and a smooth surface are bent so that one or more portions of the rough surface are present on the exposed surface of the device and the smooth surface is formed. It comprises ensuring that one or more portions are in contact with each other and are not exposed to the surface of the device, and one or more other portions of the smooth surface are exposed to the surface of the device. Bent metal porous bone internal growth devices can be attached to medical implants, coated with one or more biomaterials, or a combination thereof.

The above and other aspects, advantages and alternatives will be apparent to those skilled in the art by reading the following detailed description with reference to the accompanying drawings as appropriate.

FIG. 1A shows a porous metal scaffold bent into a single fin according to an exemplary embodiment. FIG. 1B shows the porous metal scaffold of FIG. 1A before being folded along the creases shown by the dashed lines according to one exemplary embodiment. FIG. 2A shows another porous metal scaffold before folding along the creases shown by the dashed lines according to one exemplary embodiment, along with the cutting lines shown by the solid lines. FIG. 2B shows another porous metal scaffold before being folded along the creases shown by the dashed lines according to one exemplary embodiment. FIG. 2 shows a porous metal scaffold bent into a “Y” shape formed by attaching the porous metal scaffolds of FIGS. 2A and 2B according to an exemplary embodiment to a keel. FIG. 4A shows a porous metal scaffold bent into a double fin according to an exemplary embodiment. FIG. 4B shows the porous metal scaffold of FIG. 4A before being folded along the creases shown by the dashed lines according to one exemplary embodiment. FIG. 5A shows a tibial implant formed with a T-shaped bent porous metal scaffold according to an exemplary embodiment. FIG. 5B shows a femoral implant formed by a porous metal scaffold with a bent T-shape and tube shape according to an exemplary embodiment. Shown is a "T" shaped scaffold attached to a wedge according to an exemplary embodiment.

A. Porous Metal Scaffold Discloses medical implants with one or more porous and rigid features. Porous and rigid features can have complex three-dimensional shapes. Its features help fix the medical device to the bone and also allow internal bone growth throughout the features. The device and method bring the rough surface of the feature into contact with the bone.

The devices of the present disclosure may include one or more porous metal scaffolds. Each of the one or more porous metal scaffolds may be equipped with an open-celled metal sheet scaffold. One or more porous metal scaffolds are approximately 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 58.8%, 59%, 60%, 61. Has an average porosity of%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, or more (or any range between approximately 50% and 69%). obtain. The pore size can range from approximately 200 μm to approximately 700 μm (micrometers) in diameter. For example, the pore size is approximately 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 425 μm, 450 μm, 475 μm, 500 μm, 523 μm, 525 μm, 550 μm, 575 μm, 600 μm, 625 μm, 650 μm, 675 μm, or 700 μm (or approximately 200 μm to 700 μm). Can be any range in between). Sheets of porous metal scaffolds can be approximately 0.25 mm, 0.5 mm, 0.75 mm, 1.0 mm or 1.25 mm (or any range between approximately 0.25 mm and 1.0 mm) in thickness. One or more porous metal scaffolds may have interconnected porous porosity. The pore intercity can be approximately 175 μm, 200 μm, 225 μm, 229 μm, 250 μm, 275 μm, or 300 μm (or any range between approximately 175 μm and 300 μm).

One or more porous metal scaffolds can be manufactured by the laminating method. Individual layers of metal, such as titanium, are etched to remove the material. The layers can be approximately 0.1 mm, 0.2 mm, 0.25 mm, 0.3 mm, 0.4 mm, 0.5 mm or more in thickness. Multiple layers (eg, 2 layers, 3 layers, 4 layers, 5 layers or more) are diffusion bonded together to produce interconnected continuous pores.

When one or more porous metal scaffolds are laminated or stacked, each scaffold may have the same or different pore pattern. The pore pattern can have any number of pores and any kind of pore shape.

If the pattern and size of the pores are the same, the layers can be stacked so that all the pores are aligned within the layer. Alternatively, the pores of one layer can overlap with the pores of one or more other layers. The pores penetrate a plurality of layers and have a shape determined by the overlap of the pores.

When the pore pattern of each layer (ie, the number and shape of pores) is different, the pores of one layer overlap with the pores of one or more other layers. The pores penetrate a plurality of layers and have a shape determined by the overlap of the pores.

Therefore, a single porous metal scaffold is composed of a plurality of porous layers bonded to each other (for example, 2 layers, 3 layers, 4 layers, 5 layers, 6 layers, 7 layers, 8 layers, 9 layers, 10 layers, etc. It may have 15 layers, 20 layers, or more).

In one embodiment, the one or more porous metal scaffolds are not 3D printed scaffolds, gas phase deposited scaffolds, or spray coated scaffolds (eg, titanium plasma spray coated scaffolds).

A given scaffold of one or more porous metal scaffolds, whether bonded or single layer, may be rough or sided and smooth or smooth, as described in more detail below. Can include sides. The top or side of the porous scaffold can be roughened on its surface or side by having a texture. The bottom or side of the porous scaffold lacks texture and smoothes its surface. The rough surface of the porous metal scaffold promotes internal growth of the bone, resulting in a strong bond of the scaffold to the bone. The smooth surface enhances surface contact with some of the medical implants, which provides good bond strength between the porous scaffold and the implant.

The texture of the top surface of the porous scaffold is, for example, a raised portion of a material (eg, titanium, titanium alloy (eg, Ti-6Al-4V, nitinol), cobalt-chromium alloy, niobium, tantalum, metals such as combinations thereof). It can be formed or attached to the top surface of the porous scaffold. Unlike the layered material that surrounds and defines the pores, the ridges are discontinuous with each other, giving a ridged shear section. In one embodiment, the material ridge is harder than the cortical bone. The ridge can be of any shape and can have a wide variety of different shapes (eg, circular, oval, crescent, square, rectangular, triangular, freely curved). The distribution of the ridges may be random or have a predetermined pattern. Each ridge can be formed as a thickened portion of the top surface of the porous scaffold and does not overlap with the pores formed on the top surface of the porous metal scaffold.

The ridge can have a peripheral surface that defines one or more curved parts that form a curved peripheral surface, applying shear forces to the bone when the scaffold is pressed against the bone, and also applying shearing material. It can be directed to the pores of a porous material. The ridge may also have a peripheral surface that defines a linear angle, that is, is flat. The ridge may also have a sloping edge. The ridges cover only part of the material, rather than covering the entire material that surrounds and defines the pores. The individual ridges may have different thicknesses to form the rough surface of the porous metal scaffold.

The ridges can be formed as a separate layer of material attached to the surface of the porous metal scaffold, or as an integral part of the rough surface of the porous metal scaffold. For example, the ridge can be formed from a layer of ridge material bonded to the rough surface of the porous metal scaffold. The ridge can also be created by additive manufacturing.

The texture of the rough surface of one or more porous metal scaffolds, whether formed at the ridges or by other methods (eg, scraping the surface), will be applied to the porous metal scaffold in an appropriate manner. Can be granted. In one embodiment, the height of the ridge can be approximately 100 μm, 150 μm, 200 μm, 300 μm, 400 μm, 500 μm, 600 μm, 700 μm, 800 μm, 900 μm, 1000 μm, or more. In one embodiment, the ridges should not have spatial dimensions greater than approximately 100 μm, 200 μm, 300 μm, 400 μm, 500 μm, 600 μm, 700 μm, 800 μm, 900 μm or 1000 μm, i.e. width, thickness or length. Can be formed.

In one embodiment, the ridges are connected to the scaffold top material to form a texture, but the ridges can overlap the pores formed in the porous metal scaffold. In these embodiments, the ridge not only increases the thickness of the scaffold material that surrounds and defines the pores, but also shears the bone material, directing the sheared bone material into the pores of the porous metal scaffold. ..

One or more porous metal scaffolds may include metals such as titanium, titanium alloys (eg Ti-6Al-4V, nitinol), cobalt-chromium alloys, niobium, tantalum, combinations thereof. One or more porous metal scaffolds include metals (eg, Ti, CoCr, etc.), polymers (eg, ultra-high molecular weight polyethylene (UHMWPE, ultra-high molecular weight weight polyethylene), polycarbonate urethane (PCU, polycarbonate-urethane), poly. It can easily adhere to ether ether ketone (PEEK, polycarbonate), ceramics, and other substances for medical devices.

One or more porous metal scaffolds have a high coefficient of friction μ, eg, approximately 0.80, 0.85, 0.90, 0.95, 1.00, 1.05, 1.10, 120, or the like. It has the above μ (or any μ in the range between about 0.80 and about 1.20). One or more porous metal scaffolds have a structural rigidity of approximately 2.0, 2.5, 3.0, 3.2, 3.5, 4.0 or higher (or approximately 2.0). Can have any kappa) in the range between about 4.0.

In one embodiment, one or more porous metal scaffolds have higher shear strength than PEEK, allografts, titanium plasma spray coated implants. In one embodiment, the one or more porous metal scaffolds are, for example, at about 7 MPa, 8 MPa, 9 MPa, 10 MPa, 11 MPa, 12 MPa, or more (or about 7 MPa) at 5 weeks in the pig calvaria pin removal model. Has a shear strength of (from 12M to 12M). In one embodiment, one or more porous metal scaffolds are approximately 1.5x, 1.8x, 2.0x, 2x for materials such as PEEK, allografts, titanium plasma spray coated implants, etc. 5.5 times, 3.0 times, 3.3 times, 3.5 times, 4.0 times, 4.5 times, 5.0 times, 6.0 times, 6.5 times, 6.8 times, or It has a higher shear strength.

Non-limiting examples of one or more porous metal scaffolds include BioSync®, OsteoSync®, Forticore®, InTice®, OsteoFuZe® scaffolds.

B. Bent Porous Metal Scaffolds The bent porous metal scaffolds of the present disclosure offer multiple advantages over other internal growth features and implants such as three-dimensional printed implants, vapor deposition implants, spray coated implants. Have. Three-dimensional printed implants, vapor-deposited implants, and spray-coated implants lose pores and pore structures when bent and are not as strong and rigid as the devices and features of the present disclosure. On the other hand, the bent porous metal scaffolds of the present disclosure maintain pores and pore structure even when bent, and are strong and hard.

One or more porous metal scaffolds can be bent to form a rigid and complex three-dimensional shape that can be used as a bone internal growth device or feature. The scaffold should improve the rigidity and functionality of the final structure, whether it is just a bent porous scaffold or one or more bent porous scaffolds attached to a medical device. Can be bent and sintered. The one or more porous metal scaffolds of the bone internal growth device have a rough surface and a smooth surface, one or more parts of the rough surface are present on the exposed surface of the device, and one or more parts of the smooth surface. Can be bent so that they do not come into contact with each other and are exposed to the surface of the device, and one or more portions of the smooth surface are exposed to the surface of the device. Generally, most or all of the rough surface is present on the exposed surface of the bent porous metal scaffold of the finished product. That is, approximately 55%, 60%, 70%, 75%, 80%, 90%, 95% or 100% of the rough surface of the bent porous metal scaffold is exposed on the surface of the finished device. This provides a surface area for bone attachment and internal growth. Generally, most or all of the smooth surface of the porous metal scaffold is not exposed to the outer surface of the bent metal scaffold. One or more portions of the smooth surface of the bent porous metal scaffold may come into contact with each other after bending.

In one embodiment, one or more portions of the smooth surface of the bent porous metal scaffold exposed to the surface of the device are attached to an implant such as a medical implant.

The scaffold is bent so that most or all of the rough surface is on the outside and exposed to the subject's body. The shape and roughness of the bent porous metal scaffold provides initial fixation to the bone and also provides internal bone growth into the bent porous metal scaffold. Since the bent porous metal scaffold has continuous porosity with interconnection and no solid supporting substrate, bone can grow completely over the scaffold.

Two or more porous metal scaffolds can be joined together and then bent. Alternatively, two or more porous metal scaffolds can be bent and then joined to each other. In one embodiment, two or more (eg, two, three, four, five, or more) porous metal scaffolds may be laminated together to form a laminated scaffold and then bent. can. The laminated scaffold is laminated or stacked so that one surface (for example, the top surface) is rough and the other surface (for example, the bottom surface) is smooth.

The bent porous metal scaffold (and its final implant structure) has excellent internal bone growth performance. For example, approximately 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, or more after implantation in a subject (eg, a mammal such as a human), approximately 60 voids in the porous metal scaffold. %, 70%, 80%, 90% or more can be occupied by bone. In one embodiment, approximately 75%, 80%, 85%, 90%, 95% or more of the voids are occupied by bone in 6 weeks. In one embodiment. Approximately 90% of the voids are occupied by bone 6 weeks, 8 weeks, 11 weeks, 12 weeks, or 24 weeks after implantation.

The bent porous metal scaffold (and its final implant structure) has low debris generation during insertion.

In one embodiment, the porous metal scaffold (and its final implant structure) has a degree of wear of approximately 5, 4, 3, 2, 1, 0.1 or less (ie, after multiple insertion cycles). Approximately 5%, 4%, 3%, 2%, 1%, 0.1%, or less wear). Other types of porous implants, such as titanium plasma sprayed and sintered beaded implants, have significant wear (eg, approximately 5%, 10%, 20%, 30%, 40%) after 10 insertion cycles. , Or more mass loss).

Advantageously, the bent porous metal scaffold does not have a solid support substrate and can be cut with a standard orthopedic saw blade in the event of a need for modification.

In one embodiment, prior to embedding, a device with a folded porous metal scaffold is coated, immersed or contacted with one or more biomaterials. Examples of the biological material include stem cells, bone marrow concentrate, platelet-rich plasma (PRP), transplanted tissue pieces, fine bone particles, and combinations thereof.

C. Shape of Bent Porous Metal Scaffold As described above, a given scaffold of one or more porous metal scaffolds of the present disclosure may include a rough surface or side and a smooth surface or side. By having the texture on the top or side of the porous metal scaffold, it can be a rough surface or side. The bottom or side of the porous metal scaffold lacks texture and can be a smooth surface or side. The rough surface of the porous metal scaffold promotes internal growth of the bone, resulting in a strong bond of the scaffold to the bone. The smooth surface enhances surface contact with some of the medical implants and provides good bond strength between the porous scaffold and the implant. In each embodiment described herein with reference to the drawings, one or more portions of the smooth surface are not exposed to the surface of the bent porous metal scaffold but are inside the bent structure. Also, one or more portions of the smooth surface of the bent porous metal scaffold may be exposed to the surface. The exposed smooth surface can be used to attach a bent porous metal scaffold to a medical implant, while the exposed rough surface can be used to attach a bent porous metal scaffold to a bone.

One or more porous metal scaffolds may have the desired shape, eg, "I", "U", "T", "S", "O", "C", "D". , "E", "F", "H", "J", "L", "V", "W", "X", "Z", etc. .. Other shapes include a single fin, a double fin shape, a tube shape, and a wedge shape. The shape can be designed to withstand anatomical loads, providing strong initial fixation to the bone.

Referring to the drawings, a single fin as shown in FIG. 1A can be formed by bending the porous metal scaffold 100 as shown in FIG. 1B, in which the dashed line indicates a crease. FIG. 1A shows the smooth surface 102 and the rough surface 104 of the porous metal scaffold 100. FIG. 1A further shows the raised portion 106 defining the rough surface 104 of the porous metal scaffold 100.

By bending two porous metal scaffolds (FIGS. 2A to 2B) and attaching them to each other, a "Y" shape as shown in FIG. 3 can be formed. The first porous metal scaffold 200 (FIG. 2A) can be bent along the dashed line and cut along the solid line 201. The second porous metal scaffold 202 (FIG. 2B) can be bent along the dashed line and joined together to form the "Y" shape 300 as shown in FIG. As shown in FIG. 3, the combined first porous metal scaffold 200 and second porous metal scaffold 202 may be attached to the keel 302. Such keel 302 may be used for resistance to forward shear forces.

In another example shown in FIG. 4, the porous metal scaffold 400 can be bent into the shape of a double fin. Specifically, the porous metal scaffold 400 can be bent along the dashed line shown in FIG. 4B to form the double fin shape shown in FIG. 4A. The smooth surface 402 and the rough surface 404 of the porous metal scaffold 400 are shown in FIG. 4A. FIG. 4A further shows the ridge 406 defining the rough surface 404 of the porous metal scaffold 400.

FIG. 5A shows a tibial implant 500 formed with a porous metal scaffold with a "T" shape bent. As shown in FIG. 5A, a porous metal scaffold 502 bent into a "T" shape is attached to the tibial implant 500. In one example, the smooth surface of the porous metal scaffold 502 bent into a "T" shape is bound to the tibial implant 500, while the rough surface of the T-shaped bent porous metal scaffold 502 is "T" shaped. Form the outer surface.

FIG. 5B shows a femoral implant 504 formed by a porous metal scaffold with a "T" shape 506 and a tube shape 508 bent. In one example, the smooth surface of the porous metal scaffold 506 bent into a "T" shape is bonded to the femoral implant 504, while the rough surface of the porous metal scaffold 506 bent into a T shape is "T" shaped. Form the outer surface of. Similarly, in one example, the smooth surface of the tube shape 508 is attached to the femoral implant 504, while the rough surface of the tube shape 508 forms the outer surface of the tube shape.

FIG. 6 shows a "T" shaped scaffold 600 attached to a wedge 602. Specifically, FIG. 6 shows how three porous metal scaffolds are bent and attached to each other to form a "T" shape 600. The bent porous metal scaffold can be attached, for example, to a solid titanium alloy wedge, or the solid titanium alloy wedge is covered with a porous metal scaffold of approximately 0.25 mm, 0.5 mm, or 0.1 mm.

D. Medical implants One or more portions of a bent porous metal scaffold can be attached to an implant such as a medical implant. In one embodiment, one or more smooth portions of the folded metal scaffold are attached to the implant. Medical implants include, for example, unicompartmental knee implants, knee tibial implants, knee femoral implants, all knee implants, all hip implants, ankle implants, shoulder implants, elbow implants, wrist implants, spinal implants, cervical implants. Can be mentioned.

Medical implants can be made of any material, such as metals (eg, stainless steel, cobalt-chromium alloys, titanium, titanium alloys, tantalum, zirconium alloys, OXINIUM, zirconium oxide, etc.), polymer materials (eg polyethylene (eg, polyethylene). For example, ultra-highly crosslinked polyethylene (UHXLPE, ultra-high cross-linked polymer), ultra-high molecular weight polyethylene (UHMWPE, ultra-high molecular weight polymer), polyvinylidene fluoride, polypropylene, polydimethylsiloxane, parylene polyamide. , Polymethylmethacrylate, polyamide, polyurethane), ceramics (eg, silicates, metal oxides, carbides, fire-resistant hydrides, fire-resistant sulfides, fire-resistant seleniums), other substances suitable for medical implants, or these. It can be manufactured in combination.

One or more bent metal scaffolds can be attached to medical implants by any method known in the art, such as sintering, welding, gluing, fastening, or other methods.

E. Method The method for producing the bent metal porous bone internal growth device of any of the embodiments is as described above. Specifically, the method is to bend one or more porous metal scaffolds (or one or more scaffold layers) with rough and smooth surfaces so that one or more portions of the rough surface become exposed surfaces of the device. It is provided so that one or more parts of the smooth surface are in contact with each other and are not exposed to the surface of the device, and one or more parts of the smooth surface are exposed to the surface of the device. The method may also include attaching a bent metal porous bone internal growth device to a medical implant as described above. The method may also include coating a bent metal porous bone internal growth device with one or more biomaterials.

F. Examples The following examples are for illustrative purposes only and do not limit the scope of the invention as described above in a broad sense.

Commercially available pure titanium metal scaffolds with a porosity of approximately 60%, an average pore size of approximately 434 to 660 μm, pore interconnection of approximately 229 μm, and a nominal thickness of approximately 1 mm (range 5 mm to 1 mm). It was used to construct the bone internal growth feature. As shown in FIGS. 2A to 2B, the first porous metal scaffold and the second porous metal scaffold were cut out and bent. The cutting line is that shown by 201. The two porous metal scaffolds were bent and attached to each other to form a porous metal scaffold bent in a "Y" shape as shown in FIG.

Exemplary devices and methods are disclosed herein. The term "exemplary" means "as an example, a specific example, or an example." All embodiments and features described herein as "exemplary" are not necessarily preferred or advantageous over other embodiments or features. Exemplary embodiments of the present disclosure are not limiting. Those skilled in the art will readily appreciate that certain embodiments of the systems and methods of the present disclosure can be arranged and configured in a wide variety of configurations and can be combined, all of which are envisioned in the present application. The terms used herein have the usual meaning in the art, within the context of the composition and method of the present disclosure, and within the specific context in which each term is used.

Moreover, the specific arrangements shown are not seen as limiting. It should be appreciated that other embodiments may include more or less of each element shown in a given drawing. In addition, some of the illustrated elements can be combined or omitted. Furthermore, exemplary embodiments may include elements not shown.

For measurement in the present application, "abbreviation" means ± 5%. For example, a value of approximately 100 means 95 to 105 (or any value between 95 and 105).

If a range, eg, a size range, a time range, a concentration range, is given in the specification, all intermediate and subranges thereof and all individual values within a given range are included in the present disclosure. Is. It is to be understood that any subrange or individual value within the range or subrange contained herein may be excluded from aspects of the present disclosure.

Further, when the features and embodiments of the present invention are described in a group of Markush form or other alternative form, the present invention is also used in individual items or partial item groups of the Markush form or other groups. The person skilled in the art recognizes that is described.

In the present application, "bonding" means direct and indirect. For example, member A may be directly associated with member B, or may be indirectly associated, for example, via another member C. It should be understood that it does not necessarily represent the relationships of all the various elements disclosed.

Unless otherwise noted, terms such as "first" and "second" are used merely as landmarks in the present application and do not impose requirements for the order, position, or hierarchy of the items indicated by those terms. No. Furthermore, reference to the "second" item does not require or presuppose the existence of a "first" or small number of items and / or a "third" or large number of items. Throughout the specification and the accompanying claims, the singular description includes the plural, unless otherwise noted.

References to "one embodiment" or "one example" in the present application mean that at least one embodiment includes one or more features, structures, and properties described with respect to that example. The terms "one embodiment" and "one example" in various parts of the specification may or may not refer to the same example.

In the present application, a system, device, device, structure, article, element, component, or hardware "configured" to perform a particular function may simply perform that particular function after further modification. It is not something that can actually perform that particular function without any changes. That is, a system, device, device, structure, article, element, component, or hardware that is "configured" to perform a particular function is specifically selected and formed for the purpose of performing that particular function. , Implementation, utilization, program and / or designed. As used herein, "configured to do" is a system that allows a system, device, device, structure, article, element, component, or hardware to perform a particular function without further modification. , A device, device, structure, article, element, component, or existing characteristic of hardware. For the purposes of this disclosure, a system, device, device, structure, article, element, component, or hardware described as "configured" to perform a particular function is "fitted to" perform that function. Can be additionally or alternatively described as "being" and / or "being able to operate".

Other arrangements are possible, including arrangements that include more or fewer steps than those described above, or include steps in a different order than those described above.

Although various embodiments and embodiments have been disclosed, other embodiments and embodiments will be apparent to those skilled in the art. All embodiments of the various embodiments of the present disclosure may be combined unless otherwise noted. The various aspects and embodiments of the present disclosure are illustrative and not limiting, and their true scope and gist are set forth by the claims.

100 Porous metal scaffolding 102 Smooth surface 104 Rough surface 106 Raised part

Claims (20)

A bent metal porous bone internal growth device,
It comprises one or more porous metal scaffolds having continuous pores, a rough surface and a smooth surface, the porous metal scaffold having one or more portions of the rough surface on the exposed surface of the device and said smooth. A device that is bent such that one or more parts of the surface are in contact with each other and are not exposed to the surface of the device, and one or more other parts of the smooth surface are exposed to the surface of the device. The device of claim 1, wherein one or more portions of the smooth surface exposed to the surface of the device are configured to be attached to a medical implant. The device of claim 1 or 2, wherein the one or more porous metal scaffolds comprise one or more sheets having a thickness of approximately 0.5 mm prior to bending. The device according to any one of claims 1 to 3, wherein the one or more porous metal scaffolds have a continuous pore property of about 175 μm to about 300 μm. The device according to any one of claims 1 to 4, wherein the average porosity of the one or more porous metal scaffolds is between about 50% and about 69%. The device according to any one of claims 1 to 5, wherein the one or more porous metal scaffolds each include a plurality of pores having a diameter in the range of about 400 μm to about 700 μm. The device according to any one of claims 1 to 6, wherein two or more of the one or more porous metal scaffolds are attached to each other. The device according to any one of claims 1 to 7, wherein the bent metal porous bone internal growth device is coated with one or more biological substances. The device according to claim 8, wherein the biological material comprises stem cells, bone marrow concentrate, platelet-rich plasma (PRP), transplanted tissue pieces, microscopic bone, or a combination thereof. The device according to any one of claims 1 to 9, wherein the one or more porous metal scaffolds include a continuous pore metal sheet scaffold. The device according to any one of claims 1 to 10, wherein the rough surface of the one or more porous metal scaffolds includes a plurality of material ridges. 11. The device of claim 11, wherein the plurality of material ridges forming the rough surface of the device are harder than cortical bone. 11. The device of claim 11 or 12, wherein the plurality of material ridges forming the rough surface of the device have a peripheral edge defining one or more curved portions forming a curved peripheral surface. The device according to claim 11 or 12, wherein the plurality of material ridges forming the rough surface of the device have a peripheral edge that determines a linear angle. The device according to any one of claims 11 to 14, wherein the plurality of material ridges forming the rough surface of the device have a thickness in the range of about 100 μm to about 1000 μm. (A) Medical implants and
(B) A medical device comprising the bent metal porous bone internal growth device according to any one of claims 1 to 15 attached to the medical implant. 16. The medical device of claim 16, wherein the bent metal porous bone internal growth device is coated with one or more biomaterials. The method for producing a bent metal porous bone internal growth device according to any one of claims 1 to 15.
One or more porous metal scaffolds or one or more scaffolding layers with rough and smooth surfaces are bent so that one or more portions of the rough surface are present on the exposed surface of the device and one of the smooth surfaces. A method comprising such a way that the above portions are in contact with each other and are not exposed to the surface of the device, and one or more other portions of the smooth surface are exposed to the surface of the device. 18. The method of claim 18, further comprising attaching the bent metal porous bone internal growth device to a medical implant. 18. The method of claim 18, further comprising coating the bent metal porous bone internal growth device with one or more biomaterials.

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